Centre Antoine Lacassagne
Nice, 06189, France
NCT Number: NCT03826043
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population.
These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population.
In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990.
Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients.
Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.
In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.
Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).
In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nice, 06189, France
The overall incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) is 1 per 200 cancer patients, about 5 times higher than in the general population.
These events are of crucial importance, since nearly 10% of cancer patients died from thromboembolic events (EVT), making them the second leading cause of death in this population.
In hospitalized patients, the rate seems to have increase between 1979 and 1990 from 0.6% - 2% before 1990 to 4% since 1990.
Some studies report an increase in the hospitalization cost of 38%, correlated in part with the increase in hospitalization duration related to venous thromboembolism.
Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Scores were established and validated to establish this risk and to propose prophylaxis in these patients. Guidelines exist for prophylaxis and for the treatment of these patients.
Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.
In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.
Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists. (AVK), anti-platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).
In this study, the investigator means by hypocoagulability any situation modifying the normal coagulation system, that is to say:
Some studies report an increase in the hospitalization cost of 38%, correlated in part with the increase in hospitalization duration related to venous thromboembolism.
Thrombotic risk in cancer patients is known and identified. Thrombotic complications affect the survival and quality of life of cancer patients. Scores were established and validated to establish this risk and to propose prophylaxis in these patients. Guidelines exist for prophylaxis and for the treatment of these patients.
Chemotherapy is a regular generator of cytopenia, the most prominent of which is thrombocytopenia. In addition, a prospective study of 107 cancer patients in our institution shows that almost 40% of patients over 65 years of age take anticoagulant or antiplatelet therapy.
In this specific population (i.e., with cancer and hypocoagulability), the occurrence of thrombosis poses particular problems. The prevalence and incidence of venous thrombosis in this situation is unknown and the behavior to be poorly specified.
Based on these considerations, The investigator propose a two-year prospective cohort study to explore the biological parameters of hypocoagulability and to assess the incidence and prevalence of DVT in thrombocytopenic patients on vitamin K antagonists (AVK), anti platelet aggregation (AGP) and / or direct oral anticoagulant (AOD).
In this study the investigator mean by hypocoagulability any situation modifying the normal coagulation system, that is to say:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Thrombophilia, blood count and coagulation count
Time frame: 12 months
Incidence rate of first occurrence of thromboembolic event in cancer patients, and hospitalized
Time frame: 12 months
These patients in these two situations, will be identified, during the onset of thrombosis, the results of the parameters of their blood count and their intake of antiaggregant or anticoagulant treatment.
o The state of hypocoagulability is defined by: thrombocytopenia <100000 / mm3, abnormality of one or more coagulation factors, platelet antiaggregant treatment, anticoagulant treatment of all kinds.
Time frame: 12 months
Incidence rate of first occurrence of thromboembolic events in patients with cancer, and treatment with new oral anticoagulants
Time frame: 12 months
Survival at 12 months. 12-month survival is defined as the delay between the date of inclusion and the date of death from all causes. Patients lost to follow-up will be censored on the date of the latest news. Patients will be followed for 12 months after inclusion in the study.
Time frame: 12 months
Death rate due to thrombosis is the number of deaths whose cause is thrombosis.
Time frame: 12 months
Rate of haemorrhagic complications defined by the number of haemorrhagic events, whatever the degree of severity, of biological or medicinal origin.
o A haemorrhagic event is defined as the occurrence of bleeding by rupture of a blood vessel or effusion out of a blood vessel. Bleeding may be internal or external, see the examples provided below: Internal haemorrhage: cerebral hematoma, subdural hematoma; intramuscular hematoma
Centre Antoine Lacassagne
Other
"Prospective Study Evaluating the Impact and Treatment of Thrombo-embolic Events in Patients With Cancer"
Acronym: THEO
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